Just want to ask the group for pluses/minuses of each. Also any experiences with Cetuximab.

This has been discussed in length, if you go to search, even before my time here, escpeiaaly by Charm, who recenty paseed. I made a link in one of my posts, probably last December, from MSKCC, number two CCC, sometimes number one, written to the editors of Journal of Clinical Oncology, regarding Erbitux, also known as Cetuximad. They do not recommend using it for definitive treatment in chemoradiation for locally advanced head and neck cancer outside clinical trials, due to disappointing findings. Also, they did not recommend using it with Cisplatin. There is a phase III trial going on that will show the efficacy of Cisplatin vs Erbitux, which is due to be completed in 2015. I see your signature has 3 chemo treatments, which sounds like the 3 big bag Cisplatin. Erbitux is usually given weekly, the first a loading dose, along with a Benadryl infusion, tylenol, and a lower dose, about half, the other weeks during your radiation treatment. Brian Hill made a post with Erbitux on a recent request from a member for treatment info with Orbitx or similar (sp). I will try to link the post when I get to my laptop. I had Ebitux last Oct/Nov, with Taxotere, but my treatments was for metastic recurrences, my 5th, and was not chemo naive, meaning I may have built a resistance to some chemo, have kidney disease now, so my choices are more limited.

http://jco.ascopubs.org/content/early/2012/11/30/JCO.2012.46.9049

Brian Hill's response with Erbitux is about 6 posts down, on Ina's post, Orbitux.

My husband was treated with the Cetuximab. He had the first-cycle rash (with is associated with its efficacy). We kept the rash under control with Aquaphor ointment. He was able to work for all but a couple of weeks of therapy, and has recovered very well. Charm's concerns with Cetuximab were personal (his first recurrence was after Cetuximab) and also based on comments from his doctors on their experience, not on a statistically rigorous trial. The RTOG 1016 study (which it sounds like you are in) is powered answer these questions.

It is my belief that my husband's doctors did not want to subject a scientist to a neurotoxic poison when there was a valid alternative - and it has worked out well thus far - knock wood!
Maria

Paul - I know signature stated 3 Chemo which originally was planned with Cisplatin. Now I have been accepted into the trial and await random assignment to Cisplatin or Cetuximab. Thus my curiosity.

Good luck.

James,

Can you add a Signature Line like mine and Paul's? It really helps everyone reading and especially responding to your posts.

Re your Trial, please remember this Tx is to kill your cancer and save your life. Agreeing to a Trial may benefit those yet to be treated but there is no guarantee it will benefit you and if it doesn't "benefit you" the consequences could be deadly. I was offered a Trial but decided to stick with the tried and PROVEN treatment as my life was at stake. JMO

I agree with David. This is your life. I do believe that trials are needed, but if there is a proven effective treatment I would stick with it. Not worth gambling my life on a maybe. Its different if its a non fatal disease, a do over is okay, but sometimes there are no do overs where cancer is concerned. To be honest, cisplatin is a powerful toxin. But compared to rads its okay. The effects are generally not as long term unless you get some of the more rare side effects - peripheral neuropathy, and hearing issues of course are always a possibility but if they notice this they will switch you to the older version carbo which has less of those type of issues.)

I think I would do the tried and true... then if there is a recurrence, and the tried and true didn't work I would opt for the Erbitux... just my two cents.

[quote]Clinical trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged[/quote]

HiJames

the above quote was taken from the National Comprehensive Cancer Network (NCCN) guidelines which is THE authority on cancer in the US. It is generally accepted by the medical fraternity that patients on clinical trials fare better than those who are not. One of the reasons is that the protocol is VERY strict and tests and follow ups are often more comprehensive than normal practice. A patient on a trial is less likely to slip through the cracks and more likely to have side effects uncovered and treated quickly than those who are not participating in clinical trials.

Being on a clinical trial does NOT mean that you are stuck with a treatment if it is not working or causing problems. Clinical trial protocols always allow for discontinuation for lack of efficacy or intolerable side effects.

People underestimate how toxic cisplatin can be because they have it at the same time as radiation and assume that they are the side effects of radiation. The side effects have been shown to occur more often and be more severe by using the two treatments together. Effects such as mucositis, dysphagia and taste disturbance are caused by cisplatin AND radiation. The payoff is a better survival rate. Patients are monitored very carefully on cisplatin because potentially fatal adverse events such as renal failure, cardiac arrest and anemia are not uncommon. On these boards, people regularly miss their last dose of cisplatin because their blood work has signalled the development anaemia which is serious and fatal if allowed to progress.

Cetuximab (Erbitux) has been trialled in head and neck cancer and found to be more efficacious than radiation alone. Google Bonner and 2006 and the trial will pop up for you.

cisplatin has also been trialled in head and neck cancer and found to be more efficacious than radiation alone. The trials are quite old and numerous so this has become more an accepted "known". As a result, current standard of care tends to be cisplatin plus radiation where chemoradiation is indicated.

What we DON'T know is which is more effective - cisplatin or cetuximab ... trials are in progress now (which sounds like the one you are being offered).

The doctors continue to search for better drugs and cetuximab which has been well studied in other cancers is being trialled in head and neck cancer mostly because they are hoping that it is as efficacious but the side effects won't be so severe.

Whatever arm of the study you are on, Jim, your goal is to keep on the schedule as much as possible. The early radiation sessions are particularly critical, because you want to keep blasting away at the tumor and not give it a change to take a break and start growing again.

If you are on the Cetuximab arm, that means keeping the rash tolerable. If you are on the Cisplatin arm, be sure to take the anti-nausea drug and other drugs exactly as you are directed, and to be careful of infections. In either case, keeping your nutrition and hydration up is key. The fact that you are in good condition and are not a current smoker will help you come through the treatment in good order!

Maria

Erbitux, originally used for colorectal cancer, was found to be ineffective in 40 percent of the patients due to a mutated KRAS gene. For colorectal, they now do a biomarker before using to see if a person has the mutated gene or wild type (normal) KRAS gene, which seems Erbitux, some other EGFR inibitors, works with, and even insurance can deny use based on mutation. They do not do the biomarker for Head and Neck Cancer, and say, and I was told, it doesn't apply. Charm had ascertained Erbitux did not work in 5% of HNC. Also interesting is a large percentage of the mutations appear to be in the Southern belt area. I read one suggestion having to do with sun exposure, but haven't read further about that.

Erbitux is no free ride either. They have their own side effects from severe allergic, heart failure at initial infusion or 2nd, in a small percentage, and rash, sometimes severe, which can be managed by minocycline, dryness, itching, hair loss. I needed a blood transfusion, and my creatinine raised to 2.7, so the kidneys too, plus others.

I had Cisplatin along with Taxotere, 5-FU for induction chemo in 2009, so I don't know if that was the major cause, contributor to my severe, near death reaction, needing to be hospitalized for 6 months, but I would definitely not recommend IC to anyone.

At least you will know what you are getting, instead of a placebo. Both Cisplatin and Erbitux have their positive and negative aspects, but after reading MSKCC report, a major contributor, chair to the NCCN, I question Erbitux's use too outside clinical trials.